MNH · Class II · 21 CFR 888.3070

FDA Product Code MNH: Orthosis, Spondylolisthesis Spinal Fixation

Leading manufacturers include Acromed Corp., Medtronic Sofamor Danek, Inc. and Depuyacromed.

309
Total
309
Cleared
127d
Avg days
1995
Since
309 devices
25–48 of 309
Cleared May 30, 2014
PLS (POSTERIOR LUMBAR SYSTEM)
K140787
Sintea Plustek, LLC
Orthopedic · 60d
Cleared May 20, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948
Spineart
Orthopedic · 36d
Cleared May 14, 2014
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K133153
Spinefrontier, Inc.
Orthopedic · 209d
Cleared May 07, 2014
TRUE SPINAL FUSSION SYSTEM
K133690
Innovative Surgical Designs
Orthopedic · 156d
Cleared Feb 25, 2014
PRESSON SPINAL FIXATION SYSTEM
K133287
Nexus Spine, LLC
Orthopedic · 123d
Cleared Jan 10, 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403
Spine Wave, Inc.
Orthopedic · 162d
Cleared Dec 17, 2013
PERFIX ILIAC SCREW SYSTEM
K132218
U&I Corporation
Orthopedic · 153d
Cleared Nov 25, 2013
ANAX 5.5 SPINAL SYSTEM
K132101
U&I Corporation
Orthopedic · 140d
Cleared Aug 08, 2013
CAPLOX II PEDICLE SCREW SYSTEM/TOWERLOX PEDICLE SCREW SYSTEM
K131538
Captiva Spine
Orthopedic · 71d
Cleared Aug 08, 2013
OSSEUS BLACK DIAMOND PEDICLE SCREW SYSTEM
K131810
Osseus Fusion Systems, LLC
Orthopedic · 50d
Cleared May 31, 2013
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267
Spineart
Orthopedic · 116d
Cleared Apr 12, 2013
INTRAMEDULLARY NAIL SYSTEM
K122994
Weigao Orthopaedic Device Co., Ltd.
Orthopedic · 197d
Cleared Mar 11, 2013
GSO GS1 CANNULATED SCREW SYSTEM
K123487
Gold Standard Orthopaedics, LLC
Orthopedic · 118d
Cleared Feb 15, 2013
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K123164
Spinefrontier, Inc.
Orthopedic · 129d
Cleared Jan 08, 2013
MEGA 5.5 SPINE SYSTEM
K123476
Lsk Biopartners, Inc.
Orthopedic · 56d
Cleared Jan 04, 2013
INSTINCT JAVA SYSTEM
K122592
Zimmer Spine
Orthopedic · 133d
Cleared Dec 03, 2012
GALLEON PEDICLE SCREW SYSTEM
K122814
Everest Spine, LLC
Orthopedic · 81d
Cleared Oct 23, 2012
FORTEX PEDICLE SCREW SYSTEM
K120832
X-Spine Systems, Inc.
Orthopedic · 218d
Cleared Jun 27, 2012
LDR SPINE SPINETUNE TL SPINAL SYSTEM
K120760
Ldr Spine USA, Inc.
Orthopedic · 106d
Cleared Jun 27, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016
K2m, Inc.
Orthopedic · 84d
Cleared May 15, 2012
S 100 PEDICLE SCREW SYSTEM
K111940
Renovis Surgical Technologies, LLC
Orthopedic · 312d
Cleared May 09, 2012
SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM
K120353
Bm Korea Co., Ltd.
Orthopedic · 93d
Cleared May 09, 2012
DSS STABILIZATION SYSTEM-RIGID
K120491
Paradigm Spine, LLC
Orthopedic · 82d
Cleared Dec 28, 2011
ARTS2 SPINAL FIXATION SYSTEM
K103573
Advanced Medical Technologies
Orthopedic · 387d